Table 2.
Systemic and local adverse events
Gam-COVID-Vac |
Gam-COVID-Vac-Lyo |
||||||
---|---|---|---|---|---|---|---|
rAd26-S (n=9) | rAd5-S (n=9) | rAd26-S plus rAd5-S (n=20) | rAd26-S (n=9) | rAd5-S (n=9) | rAd26-S plus rAd5-S (n=20) | ||
Systemic reactions | |||||||
Hyperthermia | |||||||
Mild (37·0–38·4°C; grade 1) | 8 (89%) | 2 (22%) | 19 (95%) | 1 (11%) | 1 (11%) | 6 (30%) | |
Moderate (38·5–38·9°C; grade 2) | 0 | 1 (11%) | 1 (5%) | 0 | 0 | 1 (5%) | |
Headache | |||||||
Mild (grade 1) | 6 (67%) | 3 (33%) | 9 (45%) | 3 (33%) | 4 (44%) | 5 (25%) | |
Moderate (grade 2) | 0 | 0 | 2 (10%) | 0 | 0 | 0 | |
Asthenia | |||||||
Mild (grade 1) | 3 (33%) | 3 (33%) | 11 (55%) | 0 | 0 | 4 (20%) | |
Muscle and joint pain | |||||||
Mild (grade 1) | 3 (33%) | 2 (22%) | 4 (20%) | 1 (11%) | 2 (22%) | 4 (20%) | |
Moderate (grade 2) | 0 | 0 | 1 (5%) | 0 | 0 | 2 (10%) | |
Heartbeat (subjective palpitation) | |||||||
Mild (grade 1) | 3 (33%) | 1 (11%) | 0 | 0 | 0 | 0 | |
Diarrhoea | |||||||
Mild (grade 1) | 1 (11%) | 0 | 3 (15%) | 0 | 0 | 0 | |
Rhinorrhoea | |||||||
Mild (grade 1) | 0 | 0 | 4 (20%) | 0 | 0 | 0 | |
Loss of appetite | |||||||
Mild (grade 1) | 2 (22%) | 0 | 1 (5%) | 0 | 0 | 0 | |
Pain in the oropharynx (pharyngalgia) | |||||||
Mild (grade 1) | 0 | 1 (11%) | 1 (5%) | 0 | 0 | 0 | |
Malaise | |||||||
Mild (grade 1) | 0 | 0 | 2 (10%) | 0 | 0 | 0 | |
Sore throat (throat irritation) | |||||||
Mild (grade 1) | 0 | 0 | 2 (10%) | 0 | 0 | 0 | |
Hives | |||||||
Mild (grade 1) | 1 (11%) | 0 | 0 | 0 | 0 | 0 | |
Nasal congestion | |||||||
Mild (grade 1) | 0 | 0 | 1 (5%) | 0 | 0 | 0 | |
Cough | |||||||
Mild (grade 1) | 0 | 0 | 1 (5%) | 0 | 0 | 0 | |
Sneezing | |||||||
Mild (grade 1) | 0 | 0 | 1 (5%) | 0 | 0 | 0 | |
Changes in laboratory variables | |||||||
Mild (grade 1) | 9 (100%) | 8 (89%) | 20 (100%) | 7 (78%) | 6 (67%) | 18 (90%) | |
Moderate (grade 2) | 0 | 1 (11%) | 0 | 0 | 0 | 0 | |
Local reactions | |||||||
Pain | |||||||
Mild (grade 1) | 7 (78%) | 5 (56%) | 8 (40%) | 5 (56%) | 7 (78%) | 12 (60%) | |
Oedema | |||||||
Mild (grade 1) | 0 | 0 | 0 | 2 (22%) | 1 (11%) | 0 | |
Hyperthermia | |||||||
Mild (grade 1) | 0 | 0 | 2 (10%) | 0 | 1 (11%) | 0 | |
Itch | |||||||
Mild (grade 1) | 1 (11%) | 0 | 0 | 0 | 0 | 0 | |
Swelling | |||||||
Mild (grade 1) | 0 | 0 | 1 (5%) | 0 | 0 | 0 |
The table shows the total number (%) of volunteers who developed adverse events, according to severity (mild [grade 1], moderate [grade 2], and severe [grade 3]). No grade 3 adverse events were reported. Some volunteers had adverse events of two degrees of severity. Gam-COVID-Vac=frozen vaccine formulation. Gam-COVID-Vac-Lyo=lyophilised vaccine formulation. rAd26-S=recombinant adenovirus type 26 carrying the gene for SARS-CoV-2 full-length glycoprotein S. rAd5-S=recombinant adenovirus type 5 carrying the gene for SARS-CoV-2 full-length glycoprotein S. SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.